For Patients

Fortesta testosterone gel is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone, such as primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired). The drug is not available as a generic. Possible side effects with use of Fortesta can include urinary problems or accidents, increased risk of prostate cancer, lower sperm count, swelling, enlarged or painful breasts, blood clots in the legs, and sleep apnea.

Fortesta is available in a gel at a concentration of 10 mg testosterone per pump. The starting dose of Fortesta is 40 mg (4 pumps) applied topically once daily in the morning. Fortesta can be dose adjusted between a minimum of 10 mg of testosterone (1 pump) and a maximum of 70 mg of testosterone (7 pumps) on the basis of total serum testosterone concentrations 2 hours post Fortesta application. In pregnant or breastfeeding women, Fortesta may cause fetal harm. Fortesta may cause serious adverse reactions in nursing infants. Pregnant women or those who may become pregnant need to be aware of the potential for transfer of testosterone from men treated with Fortesta. If a pregnant woman is exposed to Fortesta, she should be apprised of the potential hazard to the fetus. Fortesta may cause adverse reactions if accidently contacted by women or children; it can even be transferred to others topically by clothing. The safety and effectiveness of this drug in the pediatric population has not been studied; children and women should avoid topical contact on skin or clothing.

Our Fortesta Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Topical testosterone is absorbed through the skin and can cause symptoms of male features in a woman or child who comes into contact with the medication. Call your doctor if your female partner has male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any other signs of male characteristics.

Less serious side effects may include:

redness, itching, burning, or hardened skin where the skin patch is worn;

breast swelling or tenderness;

increased acne or hair growth;

headache, depressed mood; or

changes in your sex drive.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SIDE EFFECTS

Clinical Trial Experience

Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
drug cannot be directly compared to rates in the clinical trials of another
drug and may not reflect the rates observed in clinical practice.

In a controlled multicenter, open label, non-comparative
90-day clinical study, 149 hypogonadal patients were treated with FORTESTA [seeClinical Studies]. Adverse reactions occurred in 22.8% (34/149) of
patients. The most common adverse reaction reported in this study was skin
reactions associated with the site of application (16.1%; 24/149) of which 79%
(19/24) were mild, and the remainder were moderate (21%; 5/24) (Table 3).

Postmarketing Experience

The following adverse reactions
have been identified during post approval use of FORTESTA. Because these
reactions are reported voluntarily from a population of uncertain size, it is
not always possible to reliably estimate their frequency or establish a causal
relationship to drug exposure (Table 4).

Application site erythema, irritation, pruritus, and swelling; fatigue, influenza like illness, and malaise.

Investigations

Decreased serum testosterone, increased hematocrit and hemoglobin

Musculoskeletal and connective tissue disorders

Pain in extremity

Nervous system disorders

Dizziness, headache, and migraine

Reproductive system and breast disorders

Erectile dysfunction, and priapism

Skin and subcutaneous tissue disorders

Allergic dermatitis, erythema, rash, and papular rash.

Vascular disorders

Venous thromboembolism

Secondary Exposure To Testosterone
In Children

Cases of secondary exposure to
testosterone resulting in virilization of children have been reported in
postmarketing surveillance of testosterone gel products. Signs and symptoms of
these reported cases have included enlargement of the clitoris (with surgical
intervention) or the penis, development of pubic hair, increased erections and
libido, aggressive behavior, and advanced bone age. In most cases with a
reported outcome, these signs and symptoms were reported to have regressed with
removal of the testosterone gel exposure. In a few cases, however, enlarged
genitalia did not fully return to age appropriate normal size, and bone age
remained modestly greater than chronological age. In some of the cases, direct
contact with the sites of application on the skin of men using testosterone gel
was reported. In at least one reported case, the reporter considered the
possibility of secondary exposure from items such as the testosterone gel
user's shirts and/or other fabric, such as towels and sheets [see WARNINGS
AND PRECAUTIONS].